The present invention discloses a herbal formulation comprising therapeutic effective amount of plant extract of woodfordia floribunda; therapeutic effective amount of plant extract of centella asiatica; and an effective amount of at least one pharmaceutically acceptable excipient.
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1. A herbal gel formulation for inter-vaginal application consisting of:
a) a combination of a woodfordia floribunda plant polar solvent extract in the range of 0.1% w/w to 5% w/w of the herbal gel formulation and a centella asiatica plant polar solvent extract in the range of 0.1% w/w to 5% w/w of the herbal formulation, wherein the combination is in an effective amount to provide a treatment of vaginal conditions upon inter-vaginal application; and
b) at least one pharmaceutically acceptable water-based excipient to formulate the gel, in the range of 90% w/w to 98% w/w of the herbal gel formulation.
13. A herbal gel formulation for inter-vaginal application consisting essentially of:
a) a combination of a woodfordia foribunda plant polar solvent extract in the amount of 0.1% w/w to 5% w/w of the herbal gel formulation and a centella asiatica plant polar solvent extract in the amount of 0.1% w/w to 5% w/w of the herbal formulation wherein the combination is in an effective amount to provide a treatment of vaginal conditions upon inter-vaginal application;
b) Carbomer in the amount of 0.5% w/w to 1.5% w/w of the herbal gel formulation;
c) Propylene glycol in the amount of 0.01% w/w to 5% w/w of the herbal gel formulation: and
d) a sufficient amount of water to form a gel.
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This application is a § 371 National Stage Application of PCT/IN2013/000323filed 20 May 2013 which claims priority to IN 1519/MUM/2012 filed 18 May 2012(hereby specifically incorporated by reference).
Technical Field Of Invention
The present invention relates to formulation comprising herbal extracts for the treatment and prevention of vaginal conditions and diseases. More specifically, the invention relates to herbal formulation comprising therapeutic effective amount of Woodfordia floribunda plant extract; therapeutic effective amount of Centella asiatica plant extract and effective amount of at least one pharmaceutically acceptable excipient for treatment of vaginal conditions, in particular for vaginal tightening and rejuvenation.
Background And Prior Art
The vaginal tissue is stretched during vaginal child birth; the effects of which may be permanent and women tend to have medical consequences. Vaginal tissues also tend to weaken and lose their tonicity with age, local traumas, chronic infections, hormonal imbalance due to malnutrition and genetic disorders. The vagina becomes flaccid in such conditions and this can negatively interfere with the sexual response.
A loosened state of the vagina can contribute to female sexual dysfunction as natural swelling and lubrication of the vagina that occurs during an arousal phase of an intercourse may take longer to occur in the loosened state. Examples of problems related to female sexual dysfunction include, but are not limited to, a loosened, relaxed, stretched, prolapsed or atrophied state of vagina; loss of sexual arousal; pain or discomfort during intercourse (dyspareunia); diminished blood flow to the vagina and the genital area; inability to achieve orgasm and general sexual dissatisfaction.
Further, beyond the loss of sexual satisfaction, if the problem is left untreated, it can give rise to several health risks in future life. The woman may develop a feeling of frustration, a loss of self-esteem and anxiety, lack of desire, urinary incontinence and formation of unpleasant genital odour among the other side effects due to persistent condition of loosened vaginal tissue.
To address these above-described vaginal conditions and problems related to female sexual dysfunction, various gels, creams, drops, suppositories, aerosol, oil, ointment, serum for intra vaginal application have been developed. Continuous research is ongoing to develop improved compositions which provide beneficial vaginal treatment properties for a wide variety of vaginal disorders. However; there is still a need to develop a formulation having minimal side effects and also which is more efficacious than the products known in the art.
Further, the beneficial effect of extracts of herbs and other natural plant ingredients are also recognized in vaginal muscle care. Herbal remedies, are particularly desired by consumers as they are clinically proven to be safe, highly effective, and do not exhibit any side effects.
The use of papain, Lavender oil, Galactoarabinan, Magnesium Aluminum Silicate, Sweet Almond Oil, Sesame Oil, Butylene Glycol, Phyllanthus emblica fruit extract, urea, allantoin, vitamin C, tocotrienols, ubiquinone, pomegranate, colloidal gold, Tocopheryl Acetate (Vitamin E Acetate), Panthenol (Vitamin B5), etc. have been known for use in compositions for topical applications for the treatment of vaginal conditions.
Surgical procedures are also known for the treatment of vaginal conditions. Alternatively, various vaginal procedures such as vaginal tightening rejuvenation surgery etc exist for the treatment of the loosened state and other such abnormalities of the vagina. However, such surgery also implicates pain, involves high cost and potential complications, including infection, altered sensation, dyspareunia, adhesions, and scarring. Further, due to safety concerns, such vaginal procedures have become quite unpopular. (See, for example, Committee Opinion #378 of the American College of Obstetricians and Gynecologists, entitled “Vaginal Rejuvenation and Cosmetic Vaginal Procedures”, published in the September 2007 issue of Obstetrics & Gynecology).
Hence, there is a need to develop a herbal gel formulation for vaginal application, that can be manufactured in a cost effective manner and has minimal side effects along with superior anti-oxidizing, anti-aging, muscle tightening, antimicrobial, anti-inflammatory, integument, vaginal-supporting, and regenerative stimulating effect that can provide multi-faceted protection, treatment and prevention in a wide variety of vaginal conditions.
Alternatively, there is a need to effectively increase female sexual response and preventing female sexual dysfunction to create satisfactory sexual experiences for a woman and her partner. There is a need for providing moisturizing, toning and replenishing effects for vaginal rejuvenation and vaginal lubrication in women, in an effective and a hygienic manner. Moreover, there is a need for providing herbal formulation with antimicrobial effects for preventing and controlling microbial infections in vaginal conditions.
Surprisingly, the inventors have found that, herbal formulation comprising:
The present invention also relates to herbal formulation in the form of a gel.
The present invention also relates to the process for preparation of the herbal formulation comprising the steps of:
It has also been found that the herbal formulation of the present invention showed enhanced efficacy in treating vaginal conditions when compared to the individual formulations.
This and other objects are attained in accordance with the present invention wherein there are provided several embodiments for preparing herbal formulation comprising the plant extracts.
In describing the embodiments of the invention, specific terminology is resorted for the sake of clarity. However, it is not intended that the invention be limited to the specific terms so selected and it is to be understood that each specific term includes all technical equivalents that operate in a similar manner to accomplish a similar purpose.
The invention relates to herbal formulation comprising of:
According to an embodiment, Woodfordia floribunda plant extract is present in the range of 0.1% to 5% w/w of the total composition.
According to another embodiment, Centella asiatica plant extract is present in the range of 0.1% to 5% w/w of the total composition.
According to one of the embodiment, the pharmaceutically acceptable excipient can include one or more astringents, antioxidants, vaginal conditioning agents, vasodilating agents, thickening agents, preservatives, flavouring agents, lubricating agents, vitality imparter, colorants and water. However, those skilled in the art will appreciate that it is possible to utilize additional pharmaceutically acceptable excipients without departing from the scope of the present invention.
According to an embodiment, the pharmaceutically acceptable excipient is present in the range of 90% to 98% w/w of the total composition.
According to another embodiment, the pharmaceutically acceptable excipient includes at least one astringent such as potassium aluminum sulphate (alum), extract of Punica granatum, Acacia senegal, Andrographis paniculata, Curcuma comosa, Aancyelus pyrethrum (anar kara), Shilajit or combination thereof. The astringent is present in the range of 0.01% to 5.0% w/w of the total composition.
According to yet another embodiment, the pharmaceutically acceptable excipient includes at least one antioxidant such as Vitamin E, Vitamin C, Gold nanoparticles or combination thereof. The antioxidant is present in the range of 0.01% to 0.5% w/w of the total composition.
According to further another embodiment, the pharmaceutically acceptable excipient includes at least one vaginal conditioning agent such as Aloe vera, almond extract, propylene glycol, Aloe barbadensis, Tinospora cordifolia, Shilajit, glycols, glycerine, sorbitol or combination thereof. The vaginal conditioning agent is present in the range of 0.50% to 5% w/w of the total composition.
According to another embodiment, the pharmaceutically acceptable excipient can optionally include vasodilating agent can be an extract of at least one plant such as Butea frondosa, Myristica fragrans, Asparagus racemosus, Butea monosperma, Acorus callomus and Withinia somnifera. The vasodilating agent can be in a range from 1% to 5% w/w of the total composition.
According to further embodiment, the pharmaceutically acceptable excipient includes at least one thickening agent such as carbomer, sodium carboxymethylcellulose, gelatin or combination thereof. The thickening agent is present in the range of 0.5-1.5% w/w of the total composition.
According to yet another embodiment, the pharmaceutically acceptable excipient includes at least one preservative such as sodium benzoate, potassium sorbate, sodium methyl paraben, propyl paraben, benzoic acid, sodium metabisulfite, disodium EDTA, butyl paraben, chlorobutanol or combination thereof. The preservative is present in the range of 0.01-2.0% w/w of the total composition.
According to another embodiment, the pharmaceutically acceptable excipient includes a lubricating agent such as sesame oil, propylene glycol, almond oil or combination thereof. The lubricating agent is present in the range of 0.01% to 5% w/w of the total composition.
According to one of the embodiment, the pharmaceutically acceptable excipient can optionally include a vitality imparter such as gold, gold glitter and gold fine particles. The vitality imparter can be in the range of 0.01-0.05% w/w of the total composition.
According to another embodiment, the pharmaceutically acceptable excipient can optionally include a colorant such as gold colour. The colorant can be in the range of 0.01%-0.04% w/w of the total composition.
According to yet another embodiment, the pharmaceutically acceptable excipient includes flavouring agent such as apricot, vanilla, cane, berry, green apple, almond, honey and rose. The flavouring agent is present in the range of 0.01% to 0.05% w/w of the total composition.
According to another embodiment, water is present in the range of 0.01% to 90% w/w of the total composition.
According to an embodiment, the herbal formulation comprises therapeutic effective amount of Woodfordia floribunda plant extract, therapeutic effective amount of Centella asiatica plant extract, effective amount of potassium aluminum sulphate (alum), an effective amount of gold nanoparticles and effective amount of at least one pharmaceutically acceptable additive.
According to an embodiment, the herbal formulation comprises therapeutic effective amount of Woodfordia floribunda plant extract, therapeutic effective amount of Centella asiatica plant extract, effective amount of Aloe vera, effective amount of Almond, effective amount of Punica granatum, effective amount of potassium aluminum sulphate (alum), effective amount of Gold, effective amount of Vitamin E and effective amount of at least one pharmaceutically acceptable additive.
According to yet another embodiment of the invention the herbal formulation may be formulated as a gel, cream, drop, suppository, aerosol, oil, ointment or serum. The formulation is preferably in the form of a gel.
According to one embodiment, the herbal formulation comprising therapeutic effective amount of Woodfordia floribunda plant extract; therapeutic effective amount of Centella asiatica plant extract and effective amount of at least one pharmaceutically acceptable excipient is a water-based formulation for use as a topical application.
According to a further embodiment, the herbal formulation comprising therapeutic effective amount of Woodfordia floribunda plant extract; therapeutic effective amount of Centella asiatica plant extract; and effective amount of at least one pharmaceutically acceptable excipient is used as a vaginal care composition.
According to a still further embodiment, the herbal formulation comprising therapeutic effective amount of Woodfordia floribunda plant extract; therapeutic effective amount of Centella asiatica plant extract; and effective amount of at least one pharmaceutically acceptable excipient is used as an inter-vaginal composition.
According to one of the preferred embodiment, the process for preparation of the herbal formulation comprises of:
According to another preferred embodiment, the process for preparation of the herbal formulation comprises of:
Sodium hydroxide solution to obtain uniform composition;
According to another embodiment, the invention further relates to a method of application of the herbal formulation comprising effective amount of plant extract of Woodfordia floribunda plant; effective amount of extract of Centella asiatica plant; and effective amount of at least one pharmaceutically acceptable excipient.
According to another embodiment, the invention further relates to a method of treating vaginal conditions in female subjects. This method comprises administering to the female subject suffering from vaginal disorder, an effective amount of the herbal formulation comprising of a therapeutically effective amount of plant extract of Woodfordia floribunda plant; a therapeutically effective amount of extract of Centella asiatica plant; and an effective amount of at least one pharmaceutically acceptable excipient.
According to yet another embodiment, the herbal formulation of the invention is not only effective for vaginal treatment composition but also acts as an effective antioxidant, antiseptic and a lubricant in other vaginal conditions. The herbal formulation also plays an important role in the firming, tightening and for rejuvenation of the vagina.
According to another embodiment, the herbal formulation effectively heals wounds and increases vascularization of the connective tissues in other skin conditions.
From the foregoing it will be observed that numerous modifications and variations can be effectuated without departing from the true spirit and scope of the novel concepts of the present invention. It is to be understood that no limitation with respect to the specific embodiments illustrated is intended or should be inferred.
The following non-limiting examples illustrate the herbal formulation for vaginal treatment.
The process for preparation of the herbal formulation comprises of:
TABLE 1
Ingredients used in herbal formulation comprising
Sr. No.
Component
Amount used % w/w
1
Woodfordia floribunda
0.75
2
Centella asiatica
0.75
3
Punica granatum
0.75
4
Alum
0.04
5
Almond
1.5
6
Aloe vera
1.5
7
Propylene Glycol
3.04
8
Carbomer
1.25
9
Sodium hydroxide
0.25
10
Sodium benzoate
0.38
11
Potassium Sorbate
0.15
12
Vitamin E
0.02
13
Gold
0.02
14
Flavor
0.02
15
DM Water
Q.S.
The process for preparation of the herbal formulation comprises of:
TABLE 2
Ingredients used in herbal formulation comprising
Sr. No.
Component
Amount used % w/w
1
Woodfordia floribunda
0.1
2
Centella asiatica
0.1
3
Punica granatum
0.1
4
Alum
0.04
5
Almond
1.5
6
Alovera
1.5
7
Propylene Glycol
3.04
8
Carbomer
1.25
9
Sodium hydroxide
0.25
10
Sodium benzoate
0.38
11
Potassium Sorbate
0.15
12
Vitamin E
0.02
13
Gold
0.02
14
Flavor
0.02
15
DM Water
Q.S.
The process for preparation of the herbal formulation comprises of:
TABLE 3
Ingredients used in herbal formulation comprising
Sr. No.
Component
Amount used % w/w
1
Woodfordia floribunda
5
2
Centella asiatica
0.75
3
Punica granatum
2
4
Alum
1
5
Almond
0.5
6
Alovera
0.5
7
Propylene Glycol
3.04
8
Carbomer
1.25
9
Sodium hydroxide
0.25
10
Sodium benzoate
0.38
11
Potassium Sorbate
0.15
12
Vitamin E
0.25
13
Gold
0.02
14
Flavor
0.02
15
DM Water
Q.S.
The process for preparation of the herbal formulation comprises of:
TABLE 4
Ingredients used in herbal formulation comprising
Sr. No.
Component
Amount used % w/w
1
Woodfordia floribunda
0.75
2
Centella asiatica
5
3
Punica granatum
1.5
4
Alum
0.5
5
Almond
0.5
6
Alovera
1.5
7
Propylene Glycol
3.04
8
Carbomer
1.25
9
Sodium hydroxide
0.25
10
Sodium benzoate
0.38
11
Potassium Sorbate
0.15
12
Vitamin E
0.02
13
Gold
0.02
14
Flavor
0.02
15
DM Water
Q.S.
The process for preparation of the herbal formulation comprises of:
TABLE 5
Ingredients used in herbal formulation comprising
Sr. No.
Component
Amount used % w/w
1
Woodfordia floribunda
1.5
2
Centella asiatica
1.5
3
Punica granatum
0.5
4
Alum
0.04
5
Almond
0
6
Alovera
1.5
7
Propylene Glycol
3.04
8
Carbomer
1.25
9
Sodium hydroxide
0.25
10
Sodium benzoate
0.38
11
Potassium Sorbate
0.15
12
Vitamin E
0.02
13
Gold
0.02
14
Flavor
0.02
15
DM Water
Q.S.
A Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Herbal Gel Formulation According to an Embodiment of the Invention [Test Product] Vs. Placebo in Females with Vaginal Relaxation
Study Objectives:
Primary Objective:—
Treatment:
Test product—herbal formulation in accordance with an embodiment of the invention was applied 2 g once a day for period of 12 weeks in females with vaginal relaxation, Visits were scheduled as baseline visit (Visit 1) i.e. (day 1), Visit 2 (4th week), Visit 3 (8th week) and Visit 4 (12th week) after randomization to assess safety and efficacy.
Placebo was applied 2 g once a day for period of 12 weeks in females with vaginal relaxation, Visits were scheduled as baseline visit (Visit 1) i.e. (day 1), Visit 2 (4th week), Visit 3 (8th week) and Visit 4 (12th week) after randomization to assess safety and efficacy.
Efficacy and Safety Measurements:
The efficacy of the composition was evaluated on the basis of investigation of following parameters on Baseline visit (Visit 1) i.e. day 1 followed by visit 2 (4th week), visit 3 (8th week) and by the end of the therapy on visit 4 (12th week).
Improvement was Assessed by Questionnaires Administered Included Two Likert-Type Visual Analog Scale Questionnaires for Scoring Patient Reported for Vaginal Laxity/Looseness, Sexual Satisfaction were Graded as Follows:
Vaginal Laxity/Looseness
The observations were graded as follows:
1—Very Loose
2—Moderately Loose
3—Slightly Loose
4—Neither Tight nor Loose
5—Slightly Tight
6—Moderately tight
7—Very Tight
TABLE 6 (a)
Mean score (±std deviation)
Duration
Test product
Placebo
Before
4.86
4.95
pregnancy
Pre-treatment
2.38
2.22
Week 4
3.53
2.17
Week 8
3.84
2.38
Week 12
4.59
2.41
Sexual Satisfaction
The observations were graded as follows:
0—None
1—Poor
2—Fair
3—Good
4—Very Good
5—Excellent
TABLE 6 (b)
Mean score (±std deviation)
Duration
Test product
Placebo
Before
4.24
4.20
pregnancy
Pre-treatment
2.03
2.00
Week 4
3.20
2.07
Week 8
3.67
2.14
Week 12
3.98
2.20
Female Sexual Function Index (Questionnaire)
The observations were graded as follows:
1—Very low or none at all
2—Low
3—Moderate
4—High
5—Very high
TABLE 6 (c)
Mean score (±std deviation)
Duration
Test product
Placebo
Pre-treatment
3.08
3.12
Week 4
6.39
3.37
Week 8
6.68
3.53
Week 12
8.11
3.71
Symptoms of Vaginal Infections Like Vaginal Itching, Vaginal Discharge, Odour, Inflammation, Burning Pain were Evaluated; However Results of Vaginal Itching are Provided Below:
The observations were graded as follows:
0—None
1—Mild
2—Moderate
3—Severe
TABLE 6 (d)
Mean score (±std deviation)
Duration
Test product
Placebo
Pre-treatment
1.86
1.89
Week 4
1.17
1.49
Week 8
0.59
1.54
Week 12
0.23
1.43
CONCLUSION
Surprisingly, the herbal formulation of the present invention comprising of Woodfordia floribunda plant extract and Centella asiatica plant extract along with at least one pharmaceutically acceptable carriers or excipient showed persistence of significant effect upto the end of the treatment i.e. 12 weeks post treatment.
The efficacy parameters such as Vaginal Laxity/looseness; Sexual Satisfaction; Female Sexual Function Index; Symptoms of Vaginal Infections such as vaginal itching; vaginal discharge; odour; inflammation and burning pain were evaluated on the basis of ratings by the patients, which showed a significant results in the group treated with herbal formulation according to an embodiment of the invention [test product] than to the group treated with placebo that showed very less result.
Further, the degree of improvement in terms of percentage improvement in vaginal laxity, sexual satisfaction, desire, arousal, lubrication, orgasm, overall satisfaction, pain, vaginal itching, vaginal discharge, odour, inflammation, burning pain; observed as per investigator and patient evaluation was 81%, 82%, 76%, 79%, 76%, 78%, 84%, 79%, 81%, 76%, 81%, 79% and 76% respectively in the test product group.
No significant improvement was observed in placebo group. Only group with Test product showed significant improvement compared to initial value.
Also, there were no adverse reactions observed in both the test product group i.e. herbal gel formulation according to an embodiment of the invention and in the placebo group.
Moreover, the safety of the composition was also evaluated and there were no adverse events observed during the study.
Study Objectives:
Primary Objective:—
Treatment:
Test product—herbal formulation in accordance with an embodiment of the invention was applied 2 g once a day for period of 12 weeks in females with vaginal relaxation, Visits were scheduled as baseline visit (Visit 1) i.e. (day 1), Visit 2 (4th week), Visit 3 (8th week) and Visit 4 (12th week) after randomization to assess safety and efficacy.
Prior art Product was applied 2 g once a day for period of 12 weeks in females with vaginal relaxation, Visits were scheduled as baseline visit (Visit 1) i.e. (day 1), Visit 2 (4th week), Visit 3 (8th week) and Visit 4 (12th week) after randomization to assess safety and efficacy.
Efficacy and Safety Measurements:
The efficacy of the composition was evaluated on the basis of investigation of following parameters on Baseline visit (Visit 1) i.e. day 1 followed by visit 2 (4th week), visit 3 (8th week) and by the end of the therapy on visit 4 (12th week).
Improvement was Assessed by Questionnaires Administered Included Two Likert—Type Visual Analog Scale Questionnaires for Scoring Patient Reported for Vaginal Laxity/Looseness, Sexual Satisfaction were Graded as Follows:
Vaginal Laxity/Looseness
The observations were graded as follows:
1—Very Loose
2—Moderately Loose
3—Slightly Loose
4—Neither Tight nor Loose
5—Slightly Tight
6—Moderately tight
7—Very Tight
TABLE 7 (a)
COMPARISON OF MEAN SCORE OF IMPROVEMENT
IN VAGINAL LAXITY/LOOSENESS
Mean score (±std deviation)
Duration
Test product
Prior art Product
Before
4.55
4.73
pregnancy
Pre-treatment
2.39
2.34
Week 4
3.07
2.73
Week 8
3.55
3.05
Week 12
3.98
3.45
Sexual Satisfaction
The observations were graded as follows:
0—None
1—Poor
2—Fair
3—Good
4—Very Good
5—Excellent
TABLE 7 (b)
COMPARISON OF MEAN SCORE
FOR SEXUAL SATISFACTION
Mean score (±std deviation)
Duration
Test product
Prior art Product
Before
4.24
4.20
pregnancy
Pre-treatment
2.03
2.00
Week 4
3.20
2.24
Week 8
3.67
2.74
Week 12
3.98
3.20
Female Sexual Function Index (Questionnaire)
The observations were graded as follows:
1—Very low or none at all
2—Low
3—Moderate
4—High
5—Very high
TABLE 7 (c)
COMPARISON OF MEAN SCORE
FOR FEELING SEXUAL DESIRE
Mean score (±std deviation)
Duration
Test product
Prior art Product
Pre-treatment
3.00
3.00
Week 4
6.80
5.25
Week 8
7.00
6.30
Week 12
8.15
7.35
Symptoms of Vaginal Infections Like Vaginal Itching, Vaginal Discharge, Odour, Inflammation, Burning Pain were Evaluated; However Results of Vaginal Itching are Provided Below:
The observations were graded as follows:
0—None
1—Mild
2—Moderate
3—Severe
TABLE 7 (d)
Mean score (±std deviation)
Duration
Test product
Prior art Product
Pre-treatment
2.21
2.15
Week 4
1.08
1.42
Week 8
0.53
1.09
Week 12
0.24
0.70
CONCLUSION
Surprisingly, the herbal formulation of the present invention comprising of Woodfordia floribunda plant extract and Centella asiatica plant extract along with at least one pharmaceutically acceptable carrier or excipient was found to be more efficacious over the prior art product.
The efficacy parameters such as Vaginal Laxity/looseness; Sexual Satisfaction; Female Sexual Function Index; Symptoms of Vaginal Infections such as vaginal itching; vaginal discharge; odour; inflammation and burning pain were evaluated on the basis of ratings by the patients, which showed a significant results in the group treated with herbal formulation according to an embodiment of the invention [test product] than to the group treated with prior art product that showed very less results.
Further, the degree of improvement in terms of percentage improvement in vaginal laxity, sexual satisfaction, desire, arousal, lubrication, orgasm, overall satisfaction, pain, vaginal itching, vaginal discharge, odour, inflammation, burning pain; observed as per investigator and patient evaluation was 84%, 84%, 83%, 84%, 81%, 76%, 84%, 85%, 77%, 81%, 80%, 83% and 76% respectively in the test product group.
Significantly lesser improvement was observed in group treated with prior art product. Only group with test product showed significant improvement compared to initial value.
Also, there were no adverse reactions observed in the test product group and in the prior art product group.
Further, the safety of the composition was also evaluated and there were no adverse events observed during the study.
Herbal formulation comprising Woodfordia floribunda plant extracts (W1):
Component
% w/w
Woodfordia Floribunda
0.75
Punica Granatum
0.75
Alovera
1.5
Almond
1.5
Alum
0.5
Vitamin E
0.02
Gold
0.02
Flavor
0.02
DM Water
89
Herbal formulation comprising Centella asiatica plant extracts (C1):
Component
% w/w
Centella Asiatica
0.75
Punica Granatum
0.75
Alovera
1.5
Almond
1.5
Alum
0.5
Vitamin E
0.02
Gold
0.02
Flavor
0.02
DM Water
89
Herbal formulation comprising Woodfordia floribunda plant extract and Centella asiatica plant extract (F1):
Component
% w/w
Woodfordia Floribunda
0.75
Centella Asiatica
0.75
Punica Granatum
0
Alovera
1.5
Almond
1.5
Alum
0.5
Vitamin E
0.02
Gold
0.02
Flavor
0.02
DM Water
89
Comparative data of the herbal formulation indicating individual herbal ingredients (W1 & C1) vis-à-vis combination formulation (F1) in terms of vaginal laxity, sexual satisfaction and infections in female subjects at different stages of treatment:
TABLE 6
Effect of combination formulation (F1) vis-à-vis individual
formulation (W1, C1) in terms of vaginal laxity at different stages:
Stages
Placebo
W1
C1
F1
Pre-Treatment
2.22
2.25
2.30
2.28
Week 4
2.17
2.51
3.48
3.53
Week 8
2.38
2.70
2.72
2.80
Week 12
2.41
3.40
3.30
4.00
It was observed that on week 4 after treatment in relation to the vaginal tightening, the individual composition of Woodfordia floribunda plant extract (W1) gave 2.25 index value i.e. it gave 0.34 higher index than the placebo (2.51−2.17=0.34); at 2 gms once a day this corresponds to 0.34/2=0.17 more; whereas individual composition of Centella asiatica plant extract (C1) gave 2.30 index value i.e. it gave 1.31 higher index than the placebo (3.48−2.17=0.34); at 2 gms once a day this corresponds to 1.31/2=0.65 more. Thus the sum of the index value of both individual composition amounts to 0.82 more (this will be expected additive effect of both individual composition). It was observed that on week 4 after treatment the formulation comprising both the active ingredients (F1) gave 2.28 index value which is 1.36 more than placebo (3.53−2.17=1.36). Thus, the result obtained showed enhanced synergy.
Similarly, the herbal formulation of the present invention comprising of Woodfordia floribunda plant extract and Centella asiatica plant extract along with pharmaceutically acceptable carriers or excipient showed enhanced effects till the end of the treatment i.e. week 8 (0.42 more) week 12 (1.59 more) when compared to the individual formulations (W1 and C1) using same calculation. In other words, though the individual formulation W1 and C1 were found to be of little effect in the treatment but the study results in Table 6 clearly indicate that the herbal formulation provided far better synergistic effect.
TABLE 7
Effect of combination formulation (F1) vis-à-vis individual
formulation (W1, C1) in relation to sexual satisfaction
Stages
Placebo
W1
C1
F1
Pre-Treatment
2.00
2.05
2.10
2.03
Week 4
2.07
2.34
2.32
2.42
Week 8
2.14
2.62
2.65
3.67
Week 12
2.20
2.88
2.79
3.98
Surprisingly, the study demonstrated that the herbal formulation of present invention also provided high sexual satisfaction in female subjects compared to the individual formulation as evident from Table 7. The results when calculated using the calculation stated above clearly indicated that the combination formulation provides sexual satisfaction in higher degree when compared to their individual formulation; therefore the claimed herbal formulation is synergistic in nature.
TABLE 8
Effect of combination formulation (F1) vis-à-vis individual formulation
(W1, C1) with respect to vaginal infection at different stages:
Stages
Placebo
W1
C1
F1
Pre-Treatment
1.89
1.84
1.88
1.06
Week 4
1.49
1.32
1.50
1.17
Week 8
1.54
1.23
1.32
0.59
Week 12
1.43
1.10
1.06
0.23
It was observed that on treatment with the herbal formulation of the present invention comprising of Woodfordia floribunda plant extract and Centella asiatica plant extract along with pharmaceutically acceptable carriers or excipient showed decrease in symptoms of vaginal infection at the end of the treatment i.e. week 12 as compared to the individual formulations (W1 and C1) as evident from Table 8. This again indicates that the herbal formulation of the present invention when calculated using the calculation stated above provides far better synergistic effect.
While this invention has been described in detail with reference to certain preferred embodiments, it should be appreciated that the present invention is not limited to those precise embodiments. Rather, in view of the present disclosure, which describes the current best mode for practicing the invention, many modifications and variations would present themselves to those skilled in the art without departing from the scope and spirit of this invention.
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